Medicines/finished pharmaceutical products

Reference Number: 
HA659 (a)

Date of prequalification: 
10 February 2016
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Lamivudine/Zidovudine
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 150mg/300mg
Storage condition: 
SRA accepted: Store between 2°C and 30°C. Protect from moisture; WHO recommended: Do not store above 30°C. Protect from moisture
Shelf life (months): 
24
Packaging: 
Bottle,HDPE 60x1
Applicant: 
Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India
FPP Manufacturing Site: 

Lupin Ltd, Unit 2, Plot No. 2, Special Economic Zone, Phase II SEZ, Pithampur, District Dhar, Madhya Pradesh, 454 775, India
Lupin Ltd, Plot No. 15B, Phase 1 A, Verna Industrial Area, Verna, Salcette, Goa, 403722, India

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Lamivudine) Lupin Ltd, T-142, MIDC, Tarapur, Via Boisar, Thane District, Maharashtra, 401 506, India
(Lamivudine) Aurobindo Pharma Ltd, Survey No 374, Gundla, Machanoor, Mandal Hatnoora, District Medak, Andhra Pradesh, 502296, India
(Lamivudine) Aurobindo Pharma Ltd, Unit XI, Survey No 1/22, 2/1 to 5, 6 to 61 - 69, Pydibhimavaram, Mandal Ranasthalam, District Srikakulam, Andhra Pradesh, 532409, India
(Zidovudine) Hetero Labs Ltd, Unit 1, Survey No 10 IDA, Gaddapothoram Village, Kazipally, Jinnaram (M), Medak District, Andhra Pradesh, India
(Zidovudine) Mylan Laboratories Ltd, Unit 1, Survey 10/42, Gaddapotharam, Kazipally Industrial Area, Medak District, Andhra Pradesh, 502 319, India